Medical Device Assembler at Novarad Corporation

Provo, Utah, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cleanroom Operations, Quality Documentation, Product Assembly, Packaging, Sterilization Processes, Attention to Detail, Biocompatibility Testing, Inventory Control, Quality Inspections, Regulatory Compliance, Team Collaboration, Process Improvements, Gowning Procedures, Environmental Controls, Documentation, Traceability

Industry

Hospitals and Health Care

Description

Description Hi, We Are Novarad Novarad’s Enterprise Healthcare solutions help senior executives, clinicians and IT professionals deliver clinical, operational, and fiscal excellence. With a self-sustaining business model, more than three decades of technology leadership, and an intense focus on our customers’ needs, Novarad brings people and technology together in ways no one else can. We’re driven by innovation that truly transforms healthcare - for the provider and their patient. Novarad is looking for a Medical Device Assembler to support the assembly, packaging, labeling, and sterilization management of regulated medical products. This role operates in a controlled cleanroom environment and follows strict quality system requirements to ensure products meet regulatory, safety, and performance standards. The ideal candidate is detail-oriented, quality-driven, and experienced in regulated production environments, with familiarity in sterilization processes, dose audits, and biocompatibility testing workflows. This is an onsite opportunity in our Provo office. Local candidates only, please. Novarad Offers: Competitive salary with generous PTO Health, dental, vision, life, and disability insurances HSA option with dollar-for-dollar match 401k with dollar-for-dollar match Low Cost Onsite Medical Clinic Wellness program Sundance corporate passes Key Responsibilities Cleanroom Assembly & Packaging Assemble medical devices and components according to approved work instructions, drawings, and SOPs Perform sterile and non-sterile packaging operations, including sealing and labeling Verify product configuration, labeling accuracy, and lot traceability Maintain cleanroom discipline, gowning procedures, and environmental controls Maintenance of the cleanroom and production facilities Quality inspections of incoming parts Inventory control Sterilization & Quality Support Support sterilization workflows (e.g., EO, gamma, or other modalities), including preparation and documentation Assist with sterilization dose audits and verification activities Support biocompatibility testing processes, including sample preparation, documentation, and traceability Ensure products meet release criteria prior to distribution Documentation & Compliance Accurately complete batch records, device history records (DHRs), and production logs Follow all applicable quality system procedures and regulatory requirements Identify and report nonconformances, deviations, or potential quality issues Support audits and inspections by maintaining organized and compliant records Accurately complete batch records, device history records (DHRs), and production logs Follow all applicable quality system procedures and regulatory requirements Identify and report nonconformances, deviations, or potential quality issues Support audits and inspections by maintaining organized and compliant records Continuous Improvement & Teamwork Participate in training, process improvements, and corrective actions Collaborate with Quality, Engineering, and Operations teams Maintain a clean, organized, and compliant work environment Requirements Qualifications Required Qualifications High school diploma or equivalent (technical or associate degree preferred) Experience working in a regulated manufacturing environment (medical device, pharmaceutical, biotech, or similar) Familiarity with cleanroom operations and contamination control practices Experience with product assembly, packaging, sealing, and labeling Understanding of quality documentation and traceability requirements Strong attention to detail and ability to follow written procedures precisely Preferred Qualifications Manufacturing Experience in a highly regulated industry Familiarity with sterilization processes (EO, gamma, or similar) Experience supporting dose audits or sterilization validation activities Exposure to biocompatibility testing workflows or sample handling Knowledge of FDA Quality System Regulation (QSR) and ISO 13485 concepts Physical & Work Requirements Ability to work extended periods in a cleanroom environment Ability to follow gowning and PPE requirements Manual dexterity for precise assembly tasks Ability to lift up to 40 lbs, as required Novarad is an equal opportunity employer. Our recruits come from all walks of life; our customers come from all walks of life; and so do we. Novarad celebrates an inclusive and diverse workforce. This makes our team stronger by sharing our differences and experiences in open and creative conversation. Come share your differences with us.

Responsibilities

The Medical Device Assembler is responsible for assembling, packaging, labeling, and managing sterilization of regulated medical products in a cleanroom environment. This includes performing quality inspections, maintaining cleanroom discipline, and supporting sterilization workflows.